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Showing items tagged as risk

  • 2021-bl-embed-risk-based-thinking_132x132

    Embedding Risk-Based Thinking Into Quality Efforts with an Integrated Risk Management Software

    Many of the challenges inherent in developing regulated products fall into the realm of risk that manufacturers need to examine and mitigate prior to going to market. Risk management guidelines are spelled out in international regulations and standards, but true risk management goes deeper and is applied throughout the product’s life cycle.

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  • 2020-bl-rca-virtual-audits_132x132

    Adjusting to the FDA’s new Hybrid Audit and Inspection Model

    The U.S. Food and Drug Administration is changing their approach to audits. Understand how to prepare for a virtual inspection and how to ensure it goes smoothly.

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  • 2018-bl-thumb-finding-success-with-6s

    Safety Is the Key to 6S

    5S, the system of workplace standardization and organization which originated in Japan, has helped countless manufacturers reduce waste and optimize efficiency. Now, a sixth “S” is turning this lean initiative into a centerpiece of corporate culture, making it more about people than profit.

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  • smart-document-contract-132

    The Quality Metrics Journey

    One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.

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  • The Most Important Four-Letter Words in ISO 9001:2015

    Most organizations are well under way with the transition to the new ISO 9001:2015.  As such you should be very familiar with the emphasis on two four-letter words found throughout the document ….

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